UnknownNot Applicable

Effect of the Laparoscopic Approach in Reducing Postoperative Severe Complications Following Hepatectomy for Colorectal Liver Metastases

France340 participantsStarted 2021-01-27

Plain-language summary

The objective of this study is to demonstrate the superiority of the laparoscopic approach over the open approach in the resection of colorectal liver metastases, by examining the reduction of postoperative complications (including mortality), measured using the Comprehensive Complication Index (CCI) within 90 days of the procedure or regardless of the date during the hospital stay.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Presenting with colorectal liver metastases requiring liver resection ± concomitant radiofrequency ablation. * Qualifying for both a laparoscopic approach and an open approach. * Informed written consent. * Affiliated to health insurance regimen. Exclusion Criteria: * Hybrid liver resection (including both laparoscopic and open resection). * Liver resection requiring an associated vascular or biliary reconstruction. * Contraindication to surgery. * Contraindication to laparoscopy (pneumoperitoneum). * ASA (American Society of Anesthesiologists) score IV or V or life expectancy \< 3 months. * Poor comprehension of French language or cognitive impairment * Pregnancy or breastfeeding. * Patient under guardianship or unable to give consent * People particularly protected by French law.

What they're measuring

Rate of overall complications using the comprehensive complication Index (CCI)

Timeframe: Within 90 days postoperatively or at any time during hospitalization.

Trial details

NCT IDNCT04163887

SponsorInstitut Mutualiste Montsouris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-27

Contact for this trial

Caroline RIX

+33 156616371 caroline.rix@imm.fr